A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Abemaciclib: Administered orally
Tamoxifen: Administered orally
Prophylactic Loperamide: Administered orally
Study summary
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)
Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | |
| Tennessee Oncology PLLC | Nashville | Tennessee | |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | |
| University of Wisconsin Clinical Research Center | Madison | Wisconsin | |
| CENIT Centro de Neurociencias, Investigación y Tratamiento | CABA | Buenos Aires | |
| Fundacion Ars Medica | San Salvador de Jujuy | Jujuy Province | |
| Clinica Viedma | Viedma | Río Negro Province | |
| Instituto de Oncología de Rosario | Rosario | Santa Fe Province | |
| Centro Para la Atención Integral del Paciente Oncologico (CAIPO) | San Miguel de Tucumán | Tucumán Province | |
| Sanatorio Parque | Salta | Argentina | |
| Medizinische Universitaet Graz | Graz | Styria | |
| Universitätsklinik Innsbruck | Innsbruck | Tyrol | |
| AKH | Vienna | Austria | |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | |
| VITAZ | Sint-Niklaas | Oost-Vlaanderen | |
| Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | Belgium | |
| Centre Hospitalier Universitaire Sart Tilman | Liège | Belgium | |
| Hospital São Lucas - PUCRS - ONCOLOGY | Porto Alegre | Rio Grande do Sul | |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | Brazil | |
| Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA | São Paulo | Brazil | |
| Masarykuv onkologicky ustav | Brno | Czech Republic | |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | |
| Fakultni Poliklinika VFN | Prague | Czechia | |
| Fakultni Nemocnice v Motole | Prague | Czechia | |
| Thomayerova nemocnice | Praha 4 - Krc | Czechia | |
| Centre Oscar Lambret | Lille | Hauts-de-France | |
| Institut Paoli-Calmettes | Marseille | Provence-Alpes-Côte d'Azur Region | |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | |
| Kath. Marienkrankenhaus gGmbH | Hamburg | Germany | |
| Polic.Umberto I -Univ. La Sapienza | Roma | Rome | |
| Ospedale Sacro Cuore Don G. Calabria | Negrar | Verona | |
| Ospedale Bellaria - Azienda USL di Bologna | Bologna | Italy | |
| Azienda Ospedaliera Universitaria Federico II | Naples | Italy | |
| Neurociencias Estudios Clinicos | Culiacán | Sinaloa | |
| Centro Hemato Oncologico Privado | San Bernardino | Toluca | |
| Grupo Medico Camino Sc | Mexico City | Mexico | |
| Oaxaca Site Management Organization | Oaxaca City | Mexico | |
| Republic Oncology Dispensary of MoH of Republic Tatarstan | Kazan' | Russia |
+ 19 more sites — see the full list on the official registry below.
On this site
📄 Verzenio (abemaciclib) drug profile →More Eli Lilly and Company trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02747004 on ClinicalTrials.gov ↗ ← All trials in Belgium